Product Alert

Fat Loss Spas Warned About False Claims

The FDA is warning consumers about "false and misleading" claims for products used in a procedure aimed at getting rid of body fat.

The agency sent warning letters to six U.S. companies, telling them that their claims about the efficacy and safety of products used in "lipodissolve" are not supported by evidence.

A Brazilian company was also warned that its direct-to-consumer sale of the products violates several provisions of the federal Food, Drug, and Cosmetic Act.

At issue are two compounds used in the so-called lipodissolve process -- phosphatidylcholine and deoxycholate -- which "have not been evaluated or approved by the FDA for this use," the agency said.

They are claimed to be able to eliminate unwanted fat, to have an outstanding safety record, and to be superior to other fat-loss procedures, according to Kathleen Anderson, PharmD, of the FDA's Center for Drug Evaluation and Research.

Anderson told reporters in a briefing that some of the six companies claim that the procedure -- which involves injecting the compounds into pockets of fat -- can be used to treat medical conditions such as gynecomastia, lipoma, and surgical deformities.

"The FDA is not aware of any credible scientific evidence to support any of these medical uses," Anderson said.

"Claims like these mislead consumers and healthcare providers with inaccurate information," she said.

The two compounds used are components of FDA-approved drugs, but no injectable product containing either has been okayed by the agency, said Julie Golden, MD, also of the drug evaluation center.

The decision to issue the warning letters was based on examination of the Web sites of the seven companies, Anderson said, adding that other firms may be making similar claims.

"These were the firms that had the most egregious claims," she said.

Anderson added that the FDA has had five reports of adverse events after lipodissolve, including scarring, skin deformation, and deep painful knots in the area of the injections.

Because there is no requirement to report such events, she said, there may be many more.

The companies have been given 15 days to respond to the letter. If they don't satisfy the agency they could face injunctions, seizure of the products, and civil or criminal action, Anderson said.

North American Correspondent for MedPage Today, is a three-time winner of the Science and Society Journalism Award of the Canadian Science Writers' Association. After working for newspapers in several parts of Canada, he was the science writer for the Toronto Star before becoming a freelancer in 1994. His byline has appeared in New Scientist, Science, the Globe and Mail, United Press International, Toronto Life, Canadian Business, the Toronto Star, Marketing Computers, and many others. He is based in Toronto, and when not transforming dense science into compelling prose he can usually be found sailing.

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